Primary Care, Communication, and Improving Children's Health
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| ClinicalTrials.gov Identifier: NCT02277899 |
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Recruitment Status :
Completed
First Posted : October 29, 2014
Last Update Posted : May 19, 2020
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Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
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Brief Summary:
The purpose of this study is to determine communication content and strategies in primary care that predict improvement in weight status among overweight school-age children.
| Condition or disease | Intervention/treatment |
|---|---|
| Childhood Obesity Overweight Communication Weight Loss | Other: Communication regarding overweight status Other: Risk-factor assessment and counseling Other: Lifestyle behavior assessment and counseling Other: Interval follow-up to readdress weight Other: Patient-centered communication |
We will test whether 1) pediatrician-patient communication regarding overweight status, behavior/risk-factor counseling, and the frequency and time to next follow-up visit, compared with either no communication or incomplete communication (communicating only high weight status without behavior/risk-factor counseling or a follow-up visit) will predict improvement in weight status at one year follow-up, and 2) during pediatrician-patient communication regarding weight and weight management, higher patient-centeredness will predict improvement in weight status at one year follow-up. The communication content identified will generate new information about the most effective content and style of pediatrician-patient communication that predict weight-status improvement. Because we prospectively will examine clinical practice elements in the one-year interval between well-child visits, acknowledging that communication regarding high weight status may initiate assessment of risk factors for heart disease (such as high cholesterol and blood sugar), more frequent follow-up visits, or prompt a nutrition referral, we will generate novel information about the most effective clinical practices and follow-up interval and frequency that predict weight-status improvement in overweight children. We also will examine if the content and style of communication are related to improvements in diet and lifestyle behaviors at one-year follow-up.
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Primary Care, Communication, and Improving Children's Health |
| Actual Study Start Date : | October 14, 2014 |
| Actual Primary Completion Date : | August 5, 2016 |
| Actual Study Completion Date : | August 10, 2017 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Overweight school-age children
Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include:
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Other: Communication regarding overweight status
Pediatrician-patient/parent communication regarding child's high weight status Other: Risk-factor assessment and counseling Counseling regarding cardiovascular risk factor assessments/results. Other: Lifestyle behavior assessment and counseling Counseling regarding diet and lifestyle changes to improve weight status. Other: Interval follow-up to readdress weight Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program. Other: Patient-centered communication Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores. |
Primary Outcome Measures :
- Percent overweight [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]The percent over the median BMI percentile for age and gender. This measure changes comparably for similar weight changes in overweight and severely-obese children. In contrast, an overweight child would have to lose substantially less weight than a severely-obese child for the same change in BMI z-score.
Secondary Outcome Measures :
- BMI z-score [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]Change in BMI z-score of 0.25-0.5 has been associated with reductions in cardiovascular-disease risk factors. Using both percent overweight and BMI z-score measures will allow examination of the relationship between relative weight changes and cardiovascular-disease risk-factor improvement.
Other Outcome Measures:
- Change in the number of "5-2-1-0" behaviors [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]The "5-2-1-0" behaviors are: eat five fruits and vegetables, watch "screens" (TV, computer, tablets, video games, cell phones, etc…) two hours per day or less, be physically active for one hour per day or more, and drink zero calorie-containing beverages per day.
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| Ages Eligible for Study: | 6 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
We will recruit pediatricians (from academic, community, and private practices), children, and a consenting parent. Pediatricians and children will be selected to reflect the proportions of minority pediatricians and children in the practices. Pediatricians at the community and private practices will be eligible to participate if they provide outpatient pediatric care ≥20 hours/week. At the academic clinic, only second and third-year residents will be eligible. Eighty-five children and a consenting parent will be recruited.
Criteria
Inclusion Criteria:
- Schedule a well-child visit with a participating pediatrician
- Agree to return in one year for the follow-up well-child visit
- Overweight
- 6-12 years old
- Have a working telephone and/or e-mail address
- Child/parent willing to provide assent/consent
Exclusion Criteria:
- Unstable illness (such as uncontrolled asthma)
- Developmental condition (such as trisomy 21)
- Planning to move/leave practice within two years
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277899
Locations
| United States, Texas | |
| University of Texas Southwestern and Children's Medical Center | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Christy B Turer, MD, MHS | University of Texas Southwestern and Children's Medical Center Dallas |
Publications:
| Responsible Party: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT02277899 |
| Other Study ID Numbers: |
1K23HL118152-01A1 Aim 2 1K23HL118152-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 29, 2014 Key Record Dates |
| Last Update Posted: | May 19, 2020 |
| Last Verified: | May 2020 |
Keywords provided by University of Texas Southwestern Medical Center:
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childhood obesity overweight communication primary care |
weight management communication methods patient-centered communication |
Additional relevant MeSH terms:
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Pediatric Obesity Overweight Weight Loss Obesity |
Overnutrition Nutrition Disorders Body Weight Body Weight Changes |